MAUDE Adverse Event Report: MAQUET CV FUSION BIOLINE 6MM-80CM SUPP PERIPHERAL; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number VS01503086B0

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during a fem/tib bypass in the left leg of patient, after attaching the fusion bioline 6mm-80cm supp peripheral to the proximal anastomosis, there was a foam that emitted out of the distal portion of the graft.It was mixed with blood and was a deep blood color.By the time the surgeon conducted the distal anastomosis, there was no problem.The foam had been squeezed into a container and the procedure was completed successfully.Upon follow up with the physician today, ((b)(6) 2017) the patient is doing fine.The graft was implanted and a portion was kept for evaluation.

Manufacturer Narrative

(b)(4).Internal complaint number trackwise# (b)(4).Autonumber # (b)(4).Signs of clinical use and evidence of blood was observed.The device was returned in the tray with the sterile barrier open.The graft was covered in blood.The support beads on the graft were intact.There was no delamination of the beads or separation of the textile and eptfe layer observed at the two ends of the graft.There were no visual defects observed.To check if there was any leak from the graft, water was passed through the graft.There was no leak observed.The graft was submerged in the water bath and water was flown through it to observe if any foam was created.There was no foam observed.Based on the return condition of the device and the evaluation results, the reported complaint for " leak" was not confirmed.The device history records were reviewed.There were no non conformances observed.The device lot meet with all the requirements and specifications.The device lot passed all the tests with values within specifications.

Event Description

The hospital reported that during a fem/tib bypass in the left leg of patient, after attaching the fusion bioline 6mm-80cm supp peripheral to the proximal anastomosis, there was a foam that emitted out of the distal portion of the graft.It was mixed with blood and was a deep blood color.By the time the surgeon conducted the distal anastomosis, there was no problem.The foam had been squeezed into a container and the procedure was completed successfully.Upon follow up with the physician today, (b)(6) 2017) the patient is doing fine.The graft was implanted and a portion was kept for evaluation.

• Brand Name: FUSION BIOLINE 6MM-80CM SUPP PERIPHERAL
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6992779
• MDR Text Key: 91934916
• Report Number: 2242352-2017-01016
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: VS01503086B0
• Device Lot Number: 25131186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR